Test, Time, Partial Thromboplastin
Hematology · 21 CFR 864.7925
Recent MDR events
79 adverse event reports on file
- DADE ACTIN FS ACTIVATED PTT REAGENTMay 29, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00015
- DADE ACTIN FS ACTIVATED PTT REAGENTMay 29, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00016
- DADE ACTIN FSL ACTIVATED PTT REAGENTMay 15, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00012
- DADE ACTIN FSL ACTIVATED PTT REAGENTNov 10, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00051
- DADE ACTIN FSL ACTIVATED PTT REAGENTNov 10, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00052
- DADE ACTIN FSL ACTIVATED PTT REAGENTSep 12, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00044
- DADE ACTIN FSL ACTIVATED PTT REAGENTSep 12, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00045
- DADE ACTIN FSL ACTIVATED PTT REAGENTSep 12, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00046
- DADE ACTIN FS ACTIVATED PTT REAGENTJul 24, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00025
- DADE ACTIN FS ACTIVATED PTT REAGENTJul 24, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00026
Event type breakdown
Recalls
4 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.TerminatedApr 9, 2013
Dade(R) Actin(R) FSL Activated PTT Reagent.
Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
Z-1073-2013 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedFeb 16, 2012
Dade(R) Actin(R) FSL Activated PTT Reagent
The listed lots of Dade(R) Actin(R) FSL Reagent show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
Z-1043-2012 · View FDA record ↗ - Dade Behring , Inc.TerminatedDec 23, 2005
Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100
prolonged aPTT results
Z-0304-06 · View FDA record ↗ - Diagnostica Stago, Inc.TerminatedAug 30, 2005
PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Pars
Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.
Z-1419-05 · View FDA record ↗
Registered firms
28 firms currently registered for this product code
Diagnostica Stago - Taverny
Taverny Val-d'Oise, FR
Diagnostica Stago, Inc.
PARSIPPANY, NJ, US
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
R2 Diagnostics, Inc.
SOUTH BEND, IN, US
Instrumentation Laboratory Co.
ORANGEBURG, NY, US
Precision Biologic Inc.
Dartmouth Nova Scotia, CA
High Technology, Inc.
North Attleboro, MA, US
Instrumentation Laboratory Co. - Devens
Devens, MA, US
Biomedica Diagnostics Inc.
Windsor Nova Scotia, CA
Pentapharm Ag
Aesch Basel-Landschaft, CH
Hyphen Biomed Sasu
NEUVILLE SUR OISE Val-d'Oise, FR
510(k) clearances
32 clearances for this product code
- Instrumentation Laboratory (IL) Co.Mar 20, 2026
K260551 · HemosIL Factor V Leiden (APC Resistance V)
- R2 Diagnostics, Inc.Dec 30, 2010
K090105 · LUPOTEK KCT
- Aniara Diagnostica, LLCMay 8, 2009
K083729 · HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN
- Precision Biologic, Inc.May 10, 2006
K060284 · CRYOCHECK CLOT APCR
- Pentapharm , Ltd.Dec 22, 2004
K042762 · PEFAKIT APC-R FACTOR V LEIDEN
- R2 Diagnostics, Inc.Feb 4, 2004
K033471 · PHOSPHOLIN ES AND CALCIUM CHLORIDE
- Gradipore , Ltd.Dec 21, 1999
K992456 · GRADILEIDEN V TEST
- Precision Biologicals, Inc.Jan 13, 1999
K982062 · CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10